Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery
16. oktober 2016 opdateret af: Xinxin Shao, First Affiliated Hospital, Sun Yat-Sen University
Effect of Dexmedetomidine Combined With Sufentanil for Postoperative Intravenous Analgesia in Neurosurgery: A Randomized Controlled Study
The purpose of this study is to determine effect of combined medication of sufentanil and dexmedetomidine in patient controlled analgesia after neurosurgery.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sufentanil is a classical drug for postoperative analgesia.
Dexmedetomidine is a commonly used α2-adrenergic receptor, and it helps provide sedation, analgesia and inhibition of sympathetic activation.
The investigators propose to recruit 120 patients who is undergoing the arteriovenous malformation embolism operation in department of Neurosurgery.
Patients will be randomly divided into 4 groups(control group, sufentanil and low dexmedetomidine dose group, sufentanil and middle dexmedetomidine dose group, sufentanil and high dexmedetomidine dose group), then the investigators select post-operative records to determine whether dexmedetomidine can take a positive role in neurosurgical analgesia.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Rekruttering
- the First Affiliated Hospital of Sun Yetsen University
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Kontakt:
- Yi Liu, Master
- Telefonnummer: +86 13632391455
- E-mail: liuyisysu@126.com
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Kontakt:
- Nan Jiang, professor
- Telefonnummer: +86 20 28823350
- E-mail: NJiang_sysu@126.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients undergoing venous malformation embolization operation through general anesthesia.
- aged 18-65 years old.
- operating time varies 1-4h,and extubation after the operation.
Exclusion Criteria:
- long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history.
- known for dexmedetomidine or other drugs allergy in this study.
- cannot communicate.
- preoperative systolic blood pressure <90 mmHg, or the heart rate <50/min.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: sufentanil
sufentanil 150μg，intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg， intravenous administration during post-operative 72 hours.
Andre navne:
|
|
Eksperimentel: sufentanil&dexmedetomidine 1
sufentanil 150μg，dexmedetomidine 0.05μg/kg/h，intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg， intravenous administration during post-operative 72 hours.
Andre navne:
dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
Andre navne:
|
|
Eksperimentel: sufentani&dexmedetomidine 2
sufentanil 150μg，dexmedetomidine 0.1μg/kg/h，intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg， intravenous administration during post-operative 72 hours.
Andre navne:
dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
Andre navne:
|
|
Eksperimentel: sufentanil&dexmedetomidine 3
sufentanil 150μg，dexmedetomidine 0.15μg/kg/h ，intravenous administration during the following 72 hours after operation.
|
sufentanil 150μg， intravenous administration during post-operative 72 hours.
Andre navne:
dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain on the VAS scale
Tidsramme: within the following 72 hours after surgery
|
measure the VAS score at pre-operative day and post-operative 4h、8h、12h、24h、48h、72h。
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within the following 72 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
blood pressure(BP)(mmHg)
Tidsramme: within the following 72 hours after surgery
|
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
heart rate(HR) (/min)
Tidsramme: within the following 72 hours after surgery
|
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
spO2(%)
Tidsramme: within the following 72 hours after surgery
|
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
breath(/min)
Tidsramme: within the following 72 hours after surgery
|
measure BP(mmHg),HR (/min),spO2(%), and breath(/min),on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
sedation level on ramsay sedation score
Tidsramme: within the following 72 hours after surgery
|
measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
vomit times
Tidsramme: within the following 72 hours after surgery
|
measure vomit times on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
|
nausea
Tidsramme: within the following 72 hours after surgery
|
measure whether nausea exists on pre-operative day and at measure sedation level using ramsay sedation score on pre-operative day and at post-operative 4h、8h、12h、24h、48h、72h
|
within the following 72 hours after surgery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
dose of rescue tramadol
Tidsramme: within the following 72 hours after surgery
|
measure the dose of tramadol using as rescue drug on post-operative 24h、48h、72h
|
within the following 72 hours after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jiang Nan, doctor, The First Affiliated Hospital, Sun Yat-sen Unniversity
- Ledende efterforsker: Shao Xinxin, master, The First Affiliated Hospital, Sun Yat-sen Unniversity
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2015
Primær færdiggørelse (Forventet)
1. december 2016
Studieafslutning (Forventet)
1. december 2016
Datoer for studieregistrering
Først indsendt
26. maj 2015
Først indsendt, der opfyldte QC-kriterier
16. september 2015
Først opslået (Skøn)
17. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. oktober 2016
Sidst verificeret
1. oktober 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Medfødte abnormiteter
- Kardiovaskulære abnormiteter
- Vaskulære misdannelser
- Arteriovenøse misdannelser
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Analgetika, ikke-narkotisk
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Analgetika, Opioid
- Narkotika
- Hypnotika og beroligende midler
- Adjuvanser, anæstesi
- Dexmedetomidin
- Sufentanil
- Dsuvia
Andre undersøgelses-id-numre
- FirstSunYetSen-jn2015
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